AnemiaPhase 2NCT00109291
Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease
A Phase 2 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 1 site in United Kingdom.
Trial summary
To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- What is being tested?
- peginesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines;
- Males or females ≥ 18 and ≤ 75 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice an adequate form of contraception for at least 2 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after receiving study drug;
- Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60 milliliter per minute (mL/min) within 28 days prior to administration of study drug,) not requiring dialysis;
- Two hemoglobin values of ≥ 9 grams per deciliter (g/dL) and ≤ 11 g/dL within 14 days prior to administration of study drug, with one of the values drawn within 7 days prior to administration of study drug;
- One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin saturation ≥ 20% within 28 days prior to administration of study drug;
- One serum folate level above the lower limit of normal within 28 days prior to administration of study drug;
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- One vitamin B12 level above the lower limit of normal within 28 days prior to administration of study drug;
- Weight ≥ 45 kg within 28 days prior to administration of study drug;
- One white blood cell count ≥ 3.0 x 10^9/L within 28 days prior to administration of study drug; and
- One platelet count ≥ 140 x 10^9/L and ≤ 500 x 10^9/L within 28 days prior to administration of study drug.
Who cannot join
- Prior treatment with any erythropoiesis stimulating agent;
- History of pure red cell aplasia;
- Red blood cell transfusion within 3 months prior to study drug administration;
- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
- Hemolysis based on medical judgment;
- Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
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- C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration of study drug;
- Significant infection within 4 weeks prior to study drug administration, per Investigator's clinical judgment ;
- Febrile illness within 7 days prior to administration of study drug;
- Uncontrolled or symptomatic secondary hyperparathyroidism;
- Poorly controlled hypertension within 4 weeks prior to study drug administration, per Investigator's clinical judgment (e.g. systolic ≥ 170mm Hg, diastolic ≥ 100 mm Hg on repeat readings);
- Epileptic seizure in the 6 months prior to study drug administration;
- Chronic congestive heart failure (New York Heart Association Class IV);
- High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions within the past 6 months that may, in the Investigator's opinion, interfere with assessment or follow-up of the patient);
- Malignancy (except non-melanoma skin cancer);
- Life expectancy < 12 months;
- Anticipated elective surgery during the study period;
- Previous exposure to any investigational agent within 4 months prior to administration of study drug or planned receipt during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment
To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.
Read the detailed description
This was a Phase 2a, randomized, double-blind, placebo-controlled, sequential dose escalation study conducted at a single clinical center. The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort. In each treatment cohort, participants were randomly assigned to receive either a single dose of peginesatide (n=7 in the first cohort, n=4 in subsequent cohorts) or placebo (n=2 in the first cohort, n=1 in subsequent cohorts). Participants were followed for a minimum of 28 days.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Being tested
- Placebo, peginesatide
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
peginesatideDrug
Also called Omontys, Hematide, AF37702 Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single injection of placebo administered intravenously Receives: Drug: Placebo |
| Peginesatide 0.025 mg/kg | Experimental | Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. Receives: Drug: peginesatide |
| Peginesatide 0.05 mg/kg | Experimental | Single peginesatide dose of 0.05 mg/kg administered intravenously. Receives: Drug: peginesatide |
| Peginesatide 0.10 mg/kg | Experimental | Single peginesatide dose of 0.10 mg/kg administered intravenously. Receives: Drug: peginesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Measured: 28 days
Secondary outcomes (2)
Pharmacokinetic parameters
Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-∞, t½ß, Vd, Vss, and Cl
Measured: 28 days
Pharmacodynamic parameters
Pharmacodynamic parameters including reticulocytes, hemoglobin, reticulocyte hemoglobin content, and serum measures of iron stores (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: Due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affymax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Affymax, Study director, Affymax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109291
- Sponsor's protocol ID
- AFX01-02
- Other IDs
- 2005-000125-35, 2005
- Status last verified
- Dec 2012
- First submitted
- 27 Apr 2005
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment
- ClinicalTrials.gov ID
- NCT00109291
- Acronym / sponsor ID
- AFX01-02
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AffymaxIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 27 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.
Detailed description
This was a Phase 2a, randomized, double-blind, placebo-controlled, sequential dose escalation study conducted at a single clinical center. The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort. In each treatment cohort, participants were randomly assigned to receive either a single dose of peginesatide (n=7 in the first cohort, n=4 in subsequent cohorts) or placebo (n=2 in the first cohort, n=1 in subsequent cohorts). Participants were followed for a minimum of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle injection of placebo administered intravenously |
| Peginesatide 0.025 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. |
| Peginesatide 0.05 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.05 mg/kg administered intravenously. |
| Peginesatide 0.10 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.10 mg/kg administered intravenously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines;
- Males or females ≥ 18 and ≤ 75 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice an adequate form of contraception for at least 2 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after receiving study drug;
- Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60 milliliter per minute (mL/min) within 28 days prior to administration of study drug,) not requiring dialysis;
- Two hemoglobin values of ≥ 9 grams per deciliter (g/dL) and ≤ 11 g/dL within 14 days prior to administration of study drug, with one of the values drawn within 7 days prior to administration of study drug;
- One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin saturation ≥ 20% within 28 days prior to administration of study drug;
Key exclusion criteria (18 listed)
- Prior treatment with any erythropoiesis stimulating agent;
- History of pure red cell aplasia;
- Red blood cell transfusion within 3 months prior to study drug administration;
- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
- Hemolysis based on medical judgment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo |
| peginesatideAlso: Omontys, Hematide, AF37702 Injection | Drug | Peginesatide 0.025 mg/kg, Peginesatide 0.05 mg/kg, Peginesatide 0.10 mg/kg |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: 28 days
2 secondary outcomes
Pharmacokinetic parameters
Time frame: 28 days
Pharmacodynamic parameters
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Affymax study director
Affymax, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.